US11484325B2 - Patient-specific guide for repairing the pelvic bone defects depending on bone quality in fixing artificial hip joint surgeries - Google Patents

Patient-specific guide for repairing the pelvic bone defects depending on bone quality in fixing artificial hip joint surgeries Download PDF

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US11484325B2
US11484325B2 US16/763,717 US201816763717A US11484325B2 US 11484325 B2 US11484325 B2 US 11484325B2 US 201816763717 A US201816763717 A US 201816763717A US 11484325 B2 US11484325 B2 US 11484325B2
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openings
patient
fasteners
specific guide
internal surface
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US20200337714A1 (en
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Mahmoud Alm EL Din HAFEZ
Ahmed Abdel Moghny SALEM
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1742—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the hip
    • A61B17/1746—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the hip for the acetabulum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1735—Guides or aligning means for drills, mills, pins or wires for rasps or chisels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B2017/568—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor produced with shape and dimensions specific for an individual patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/108—Computer aided selection or customisation of medical implants or cutting guides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4609—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of acetabular cups
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30576—Special structural features of bone or joint prostheses not otherwise provided for with extending fixation tabs
    • A61F2002/30578—Special structural features of bone or joint prostheses not otherwise provided for with extending fixation tabs having apertures, e.g. for receiving fixation screws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30948—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using computerized tomography, i.e. CT scans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4687—Mechanical guides for implantation instruments
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00—Products made by additive manufacturing

Definitions

  • This invention relates to a patient specific guides for hip replacement for patients who going to hip replacement surgery.
  • Hip joint especially the acetabulum
  • acetabulum is innate in the body and hence it is almost unseen. Therefore, performing artificial pelvic joint fixation surgeries requires accurate surgical planning by a skillful and experienced surgeon.
  • Many surgeons depend on patient-specific guides (templates) for specifying the position and path of fastening screws of the pelvic bone acetabulum.
  • the currently available guide is the three-cylinder fixation guide.
  • the cylinders are connected to a central cylinder for making one central opening of five or six openings required for fixing the artificial hip joint acetabulum.
  • a computer-assisted surgery pre-planning and the resulting production of patient-specific guides have solved some common problems related to traditional tools.
  • Present guides give only information about the central opening (the middle screw opening) of the pelvic joint acetabulum.
  • Their design does not allow the surgeon to specify the place and status of the guide on the cotyloid cavity for being composed of three fixation cylinders with small surface areas that do not completely cover the bone surface.
  • the cylinders are connected to a spaced central cylinder through arms.
  • the present invention provides a patient-specific guide for fixing the pelvic joint acetabulum for patients undergoing pelvic joint replacement surgery.
  • the guide consists of two parts: one for the pubic part and the one for the ischial part of the pelvic joint's cotyloid cavity. It is designed to correct defects of the acetabulum and guides surgeons to the optimal places for fixing the artificial joint screws, specifying their diameters and lengths according to the case and the pelvic bone status.
  • the internal guide surface is an imprint of the pelvic bone. Hence, it is accurately fixed on the bone according to its anatomy and the vivid markers on the pelvic bone surface. This is advantageous in complicated cases in particular, such as bone corrosion, fractures and tumors.
  • the present invention provides a patient-specific guide for mounting an artificial pelvic joint.
  • the guide consists of two parts for making paths for fastening screws of the pelvic joint acetabulum: one for making the pubic part's screw paths of the acetabulum cavity (the upper part), and one for making the ischial part's screw paths of the acetabulum cavity (the lower part).
  • the guide takes the shape of an evacuated hemi-sphere; each part includes four openings for its fixation on the upper surface of the cotyloid cavity, in addition to fastening and alignment arms on the surface of the bottom cavity.
  • the template's internal surface has a topology identical to the anatomical structure of the acetabular hole. See FIGS. 1, 2, 3 & 4 .
  • the guide is designed for correcting pelvic defects depending on a design premade by the finite element method. It determines the quality and density of the bone and guides surgeons to the optimal places for fixing artificial joint screws and specifying their diameters and lengths in accordance to the medical case and pelvic bone status.
  • the internal guide's surface is an imprint of the pelvic bone. Hence, it is accurately fixed on the bone according to its anatomy and the vivid markers on the pelvic bone surface. This is advantageous in complicated cases in particular, such as bone corrosion, fractures and tumors.
  • Tomography scan pictures are used for designing a three-dimensional model for the pelvic bone.
  • the finite element method as well as the computer-assisted surgery preplanning is applied for stress analysis.
  • Surgical preplanning depends on the quality and thickness of the pelvic joint acetabulum cavity, the degree of bone corrosion and the presence of former fractures. Places, paths, diameters and lengths of fastening screws of the pelvic joint acetabulum are specified by considering the mechanical and anatomical axes.
  • the guide consists of two parts, one for making the upper part's screw paths, and one for making the lower part's screw paths of the pelvic joint acetabulum.
  • the guide takes the shape of an evacuated semi-sphere; each part contains four openings for its fixation on the upper surface of the acetabulum cavity (see FIGS. 1 & 2 ).
  • the pubic part of the guide contains two arms for fixation and alignment on the acetabular bone. However, fixation and alignment arms are connected as a whole circuit in the ischial part of the guide.
  • the pubic part of the guide contains five openings for specifying the position, path, diameter and length of the fastening screws for the thigh joint acetabulum.
  • the ischial part contains three openings for specifying the position, path, diameter and length of the fastening screws for the thigh joint acetabulum.
  • the angles, spaces and inclinations between these eight openings are identical to those of the pelvic joint acetabulum—that is to be fixed—in accordance to the manufacturer's instructions.
  • the surgeon will, therefore, be able to determine the position, path, diameter and length of the fastening screws of the pelvic joint acetabulum before surgery. He will also manage to determine the quality, density and thickness of the bone in the place of joint fixation ( FIGS. 1 & 2 ).
  • the internal surface of both the pubic and the ischial parts has surface topology that matches that of the acetabular bone cavity for ease of fixation.
  • the topology of the internal template surface is identical to the anatomical structure of the acetabular hole, making it an anatomical guide and distinct marker for guide fixation on the bone surface.
  • This internal surface whose area covers more than half of the surface area of the acetabular bone cavity, prevents the template's motion or rotation. Hence, it becomes easier for the surgeon to fix the guide in a specific position on the bone, being a patient-specific template that matches the anatomical shape of the bone scanned by tomography scan ( FIGS. 5 & 6 ).
  • Previous electronic guides have a design based only on three fixation cylinders with small surface areas that do not cover the complete bone surface.
  • the cylinders are connected to a spaced central cylinder through arms. Hence, it is not possible to accurately determine the correct path of the drilling rig that makes screw paths. It is also difficult to specify the deviation of the rig's path from the correct one.
  • the inventive guide solves these traditional problems by fixing the guide on the bone using two elements.
  • the first one is fastening openings above the guide's pubic and ischial parts on the upper border of the acetabular bone.
  • This border is considered a distinct anatomical marker easy to be recognized by the surgeon. It imparts stiffness and steadiness to the guide on the bone surface.
  • the second element used in fixation is the internal guide surface, with both pubic and ischial parts, whose topology matches the topology of the external surface of the acetabular bone cavity. It is rested on the acetabular hole which is an anatomical guide and distinct marker for guide fixation on the bone surface.
  • the internal guide surface ensures the fixation of the template in its desired position without the possibility of displacement or rotation.
  • Surgical preplanning depends on inputting data taken from the patient's tomography scan into the concerned program.
  • Tomography scan gives a vivid image of the bone alone without cartilages or soft tissues.
  • tomography scan gives the same image per patient unlike resonance that gives different images by time due to the change of cartilage status and its erosion percentage.
  • the inputted data is then converted into a three-dimensional model for the acetabular bone.
  • Surgery pre-planning is performed as above-mentioned depending on the anatomical axes and markers for the pelvic joint.
  • Surgical preplanning overcomes a prior art problem: the disability to specify the quality, thickness and density of the acetabular bone, and hence determining the positions, paths, diameters and lengths of fastening screws of the pelvic joint's acetabular bone without contacting areas of low bone quality and thickness.
  • the prior art guide cannot specify the quality, thickness and density of the bone; a fact that threatens surgery success.
  • the program searches for an electronic form for the guide according to the positions, paths, diameters and lengths of the fastening screws of the pelvic joint's acetabular part.
  • the guide's internal surfaces are identical to the bone's external surface for accurate fixation.
  • the electronic template file is sent to a three-dimensional printer to be manufactured using nylon, a medical material approved by American Food and Drug Administration (FDA).
  • FDA American Food and Drug Administration
  • the template is then used in performing pelvic joint fixation surgery.
  • each guide there is an imprinted code on the guide's body including data about the joint size and direction (right or left one) and the patient's name to avoid guides mingling.
  • the inventive guide is easy to sterilize, easy to carry and handle for its light weight. It does not exceed 50 gram, unlike traditional devices that exceed 50 kilograms in weight and consists of many boxes making them difficult to carry and sterilize.
  • the invention relates to a patient-specific guide for fixing the acetabulum of the pelvic joint for patients undergoing hip joint replacement.
  • the guide consists of two parts: one for the pubic part and one for the ischial part of the pelvic joint's cotyloid cavity. It is used for specifying the position, path, diameter and length of fastening screws for the hip joint acetabulum. It is used for complicated cases, such as bone loss and corrosion as well as fractures and tumors.
  • the template is manufactured using three-dimensional printers. It fits one patient only for being designed according to the concerned patient's tomography scan.
  • FIG. 1 represents a two-dimensional plan view for the pubic part of the guide specific for patients undergoing surgery of artificial hip joint fixation. It shows fastening openings ( 1 ), openings for determining fastening screw paths for the hip joint acetabulum ( 3 ) and fixation and alignment arms on the pubic part of the acetabular bone ( 2 ).
  • FIG. 2 represents a two-dimensional plan view for the ischial part of the guide specific for patients undergoing surgery of artificial hip joint fixation. It shows fastening openings ( 1 ), openings for determining fastening screw paths for the hip joint acetabulum ( 3 ).
  • FIG. 3 represents a two-dimensional side elevation for the pubic part of the guide specific for patients undergoing surgery of artificial hip joint fixation ( 5 ). It appears in its proper place on the acetabular bone ( 4 ).
  • FIG. 4 represents a two-dimensional side elevation for the ischial part of the guide specific for patients undergoing surgery of artificial hip joint fixation ( 5 ). It appears in its proper place on the acetabular bone ( 4 ).
  • FIG. 5 represents a three-dimensional back perspective view for the pubic part of the guide specific for patients undergoing surgery of artificial hip joint fixation.
  • the anatomical topology ( 7 ) of the guide's back surface appears in the figure which matches that of the acetabular bone's surface at its fixation place.
  • FIG. 6 represents a three-dimensional back perspective view for the ischial part of the guide specific for patients undergoing surgery of artificial hip joint fixation.
  • the anatomical topology ( 7 ) of the guide's back surface appears in the figure which matches that of the acetabular bone's surface at its fixation place.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Dentistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)
US16/763,717 2017-11-13 2018-11-08 Patient-specific guide for repairing the pelvic bone defects depending on bone quality in fixing artificial hip joint surgeries Active US11484325B2 (en)

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EG2017110030 2017-11-13
EG2017110030 2017-11-13
EG2018050804 2018-05-13
EG2018050804 2018-05-13
PCT/EG2018/000029 WO2019091538A1 (en) 2017-11-13 2018-11-08 A patient-specific guide for repairing the pelvic bone defects depending on bone quality in fixing artificial hip joint surgeries

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US11484325B2 true US11484325B2 (en) 2022-11-01

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11944392B2 (en) 2016-07-15 2024-04-02 Mako Surgical Corp. Systems and methods for guiding a revision procedure

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110184419A1 (en) * 2006-02-27 2011-07-28 Biomet Manufacturing Corp. Patient-specific acetabular guides and associated instruments
US20140012266A1 (en) * 2010-08-12 2014-01-09 Smith & Nephew, Inc. Methods and devices for installing standard and reverse shoulder implants
US20140135940A1 (en) * 2009-12-29 2014-05-15 Mobelife Nv Customized surgical guides, methods for manufacturing and uses thereof
WO2014089291A1 (en) 2012-12-05 2014-06-12 Smith & Nephew, Inc. Orthopedic guide systems and methods
US20140163564A1 (en) 2012-12-11 2014-06-12 Biomet Manufacturing Corporation Patient-Specific Acetabular Guide For Anterior Approach
US20140276870A1 (en) 2013-03-13 2014-09-18 Biomet Manufacturing Corporation Universal Acetabular Guide And Associated Hardware
US20150012001A1 (en) 2013-07-02 2015-01-08 Inova Health System Device For A Patient-Specific Acetabulum Reaming And Cup Positioning Guide

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110184419A1 (en) * 2006-02-27 2011-07-28 Biomet Manufacturing Corp. Patient-specific acetabular guides and associated instruments
US20140135940A1 (en) * 2009-12-29 2014-05-15 Mobelife Nv Customized surgical guides, methods for manufacturing and uses thereof
US20140012266A1 (en) * 2010-08-12 2014-01-09 Smith & Nephew, Inc. Methods and devices for installing standard and reverse shoulder implants
WO2014089291A1 (en) 2012-12-05 2014-06-12 Smith & Nephew, Inc. Orthopedic guide systems and methods
US20140163564A1 (en) 2012-12-11 2014-06-12 Biomet Manufacturing Corporation Patient-Specific Acetabular Guide For Anterior Approach
US20140276870A1 (en) 2013-03-13 2014-09-18 Biomet Manufacturing Corporation Universal Acetabular Guide And Associated Hardware
US20150012001A1 (en) 2013-07-02 2015-01-08 Inova Health System Device For A Patient-Specific Acetabulum Reaming And Cup Positioning Guide

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11944392B2 (en) 2016-07-15 2024-04-02 Mako Surgical Corp. Systems and methods for guiding a revision procedure

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US20200337714A1 (en) 2020-10-29
WO2019091538A1 (en) 2019-05-16

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